ESSURE
Report
- Report Number
- 2951250-2017-08896
- Event Type
- Injury
- Date Received
- November 27, 2017
- Date of Event
- June 6, 2012
- Report Date
- September 24, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND MENORRHAGIA ("MENORRHAGIA/HEAVY MENSES") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627305) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HERPES LABIALIS, VERTIGO, UPPER RESPIRATORY INFECTION AND MYOFASCIAL PAIN SYNDROME. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR (ZOVIRAX), ALPRAZOLAM, AMPICILLIN, AZITHROMYCIN, CEFAZOLIN, CIPROFLOXACIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE (DEPO PROVERA), NAPROXEN, PANADEINE CO (TYLENOL #3) AND ZOLPIDEM. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). IN 2012, THE PATIENT EXPERIENCED NECK PAIN ("NECK PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("PANIC ATTACKS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE LEIOMYOMA ("UTERINE FIBROIDS"), ANXIETY DISORDER ("ANXIETY DISORDER"), DEPRESSION ("DEPRESSION"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA OF VAGINA"), BIOPSY ENDOMETRIUM ("ENDOMETRIUM BIOPSY"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ARTHRALGIA ("MULTIPLE JOINT PAIN"), DERMAL CYST ("PILAR CYSTS ON SCALP"), EXCESSIVE GRANULATION TISSUE ("ABNL GRANULATION TISSUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("BACK PAIN"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), PAIN IN EXTREMITY ("BALL OF FOOT PAIN") AND SWELLING ("SWELLING"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (ABLATION) AND SURGERY (ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA, ANXIETY DISORDER, DEPRESSION, PANIC ATTACK, INSOMNIA, FIBROMYALGIA, MIGRAINE, HEADACHE, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, DYSURIA, BIOPSY ENDOMETRIUM, FATIGUE, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, ARTHRALGIA, DERMAL CYST, EXCESSIVE GRANULATION TISSUE, ABDOMINAL DISTENSION, NECK PAIN, BACK PAIN, PAIN IN EXTREMITY AND SWELLING OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BACTERIAL VAGINOSIS, BIOPSY ENDOMETRIUM, DEPRESSION, DERMAL CYST, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSURIA, EXCESSIVE GRANULATION TISSUE, FATIGUE, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, INSOMNIA, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PANIC ATTACK, PELVIC PAIN, SWELLING, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN D DEFICIENCY, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER PHYSICIAN DETERMINED THAT HER PHYSICAL EXAMINATION WAS SUGGESTIVE OF ESSURE DEVICE RELATED SYMPTOMS. HER PHYSICIAN DETERMINED TO TREAT HER SYMPTOMS THROUGH A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE. STEROSALPINGOGRAM CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-APR-2018: PFS AND MEDICAL RECORD RECEIVED:THE EVENT ABNORMAL VAGINAL BLEEDING, MENORRHAGIA/HEAVY MENSES, ANXIETY DISORDER, DEPRESSION, PANIC ATTACKS, INSOMNIA, FIBROMYALGIA, MIGRAINES, HEADACHES, BACTERIAL VAGINOSIS, CANDIDA OF VAGINA, DYSURIA, ENDOMETRIUM BIOPSY, FATIGUE, WEIGHT GAIN, GERD, MULTIPLE JOINT PAIN, PILAR CYSTS ON SCALP, ABNL GRANULATION TISSUE, BLOATING, VAGINAL DISCHARGE, NECK PAIN, BACK PAIN, VITAMIN D DEFICIENCY, BALL OF FOOT PAIN, SWELLING ADDED. EVENTS OUTCOME,REPORTERS,LOT NUMBER,CONCURRENT CONDITION, MEDICAL HISTORY, CONCOMITANT MEDICATION ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND MENORRHAGIA ("MENORRHAGIA/HEAVY MENSES") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627305) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HERPES LABIALIS, VERTIGO, UPPER RESPIRATORY INFECTION AND MYOFASCIAL PAIN SYNDROME. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR (ZOVIRAX), ALPRAZOLAM, AMPICILLIN, AZITHROMYCIN, CEFAZOLIN, CIPROFLOXACIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE (DEPO PROVERA), NAPROXEN, PANADEINE CO (TYLENOL #3) AND ZOLPIDEM. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). IN 2012, THE PATIENT EXPERIENCED NECK PAIN ("NECK PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("PANIC ATTACKS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE LEIOMYOMA ("UTERINE FIBROIDS"), ANXIETY DISORDER ("ANXIETY DISORDER"), DEPRESSION ("DEPRESSION"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA OF VAGINA"), BIOPSY ENDOMETRIUM ("ENDOMETRIUM BIOPSY"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ARTHRALGIA ("MULTIPLE JOINT PAIN"), DERMAL CYST ("PILAR CYSTS ON SCALP"), EXCESSIVE GRANULATION TISSUE ("ABNL GRANULATION TISSUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("BACK PAIN"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), PAIN IN EXTREMITY ("BALL OF FOOT PAIN") AND SWELLING ("SWELLING"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (ABLATION) AND SURGERY (ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA, ANXIETY DISORDER, DEPRESSION, PANIC ATTACK, INSOMNIA, FIBROMYALGIA, MIGRAINE, HEADACHE, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, DYSURIA, BIOPSY ENDOMETRIUM, FATIGUE, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, ARTHRALGIA, DERMAL CYST, EXCESSIVE GRANULATION TISSUE, ABDOMINAL DISTENSION, NECK PAIN, BACK PAIN, VITAMIN D DEFICIENCY, PAIN IN EXTREMITY AND SWELLING OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BACTERIAL VAGINOSIS, BIOPSY ENDOMETRIUM, DEPRESSION, DERMAL CYST, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSURIA, EXCESSIVE GRANULATION TISSUE, FATIGUE, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, INSOMNIA, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PANIC ATTACK, PELVIC PAIN, SWELLING, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN D DEFICIENCY, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER PHYSICIAN DETERMINED THAT HER PHYSICAL EXAMINATION WAS SUGGESTIVE OF ESSURE DEVICE RELATED SYMPTOMS. HER PHYSICIAN DETERMINED TO TREAT HER SYMPTOMS THROUGH A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE STEROSALPINGOGRAM CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), DYSFUNCTIONAL UTERINE BLEEDING ('DYSFUNCTIONAL UTERINE BLEEDING') AND MENORRHAGIA ('MENORRHAGIA/HEAVY MENSES') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627305) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CONJUNCTIVITIS, MENOPAUSE AND ALLERGIC RHINITIS. CONCURRENT CONDITIONS INCLUDED HERPES LABIALIS, VERTIGO, UPPER RESPIRATORY INFECTION AND MYOFASCIAL PAIN SYNDROME. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR, ALPRAZOLAM, AMPICILLIN, AZITHROMYCIN, CEFAZOLIN, CIPROFLOXACIN, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), DULOXETINE HYDROCHLORIDE (CYMBALTA), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NAPROXEN, ZOLPIDEM AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING, SPOTTING"). IN 2012, THE PATIENT EXPERIENCED NECK PAIN ("NECK PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("PANIC ATTACKS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY DISORDER ("ANXIETY DISORDER"), DEPRESSION ("DEPRESSION"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA OF VAGINA"), FATIGUE ("FATIGUE"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ARTHRALGIA ("MULTIPLE JOINT PAIN"), DERMAL CYST ("PILAR CYSTS ON SCALP"), EXCESSIVE GRANULATION TISSUE ("ABNL GRANULATION TISSUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("BACK PAIN"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), PAIN IN EXTREMITY ("BALL OF FOOT PAIN,WHEN I TURN A CERTAIN WAY OR SNEEZE"), SWELLING ("SWELLING") AND IRON DEFICIENCY ("IRON DEFICIENCY") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"), BIOPSY ENDOMETRIUM ("ENDOMETRIUM BIOPSY") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, SHE UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA, ANXIETY DISORDER, DEPRESSION, PANIC ATTACK, INSOMNIA, FIBROMYALGIA, MIGRAINE, HEADACHE, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, DYSURIA, BIOPSY ENDOMETRIUM, FATIGUE, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, ARTHRALGIA, DERMAL CYST, EXCESSIVE GRANULATION TISSUE, ABDOMINAL DISTENSION, NECK PAIN, BACK PAIN, VITAMIN D DEFICIENCY, PAIN IN EXTREMITY, SWELLING AND IRON DEFICIENCY OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BACTERIAL VAGINOSIS, BIOPSY ENDOMETRIUM, DEPRESSION, DERMAL CYST, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSURIA, EXCESSIVE GRANULATION TISSUE, FATIGUE, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, INSOMNIA, IRON DEFICIENCY, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PANIC ATTACK, PELVIC PAIN, SWELLING, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN D DEFICIENCY, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER PHYSICIAN DETERMINED THAT HER PHYSICAL EXAMINATION WAS SUGGESTIVE OF ESSURE DEVICE RELATED SYMPTOMS. HER PHYSICIAN DETERMINED TO TREAT HER SYMPTOMS THROUGH A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE. IMAGING PROCEDURE - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: STEROSALPINGOGRAM CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES CURRENT WEIGHT 147 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-JUN-2020: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- IRON DEFICIENCY. MEDICAL HISTORY, LAB DATA, CONCOMITANT DRUG WERE ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), DYSFUNCTIONAL UTERINE BLEEDING ('DYSFUNCTIONAL UTERINE BLEEDING') AND MENORRHAGIA ('MENORRHAGIA/HEAVY MENSES'). IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627305), INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED: CONJUNCTIVITIS, MENOPAUSE AND ALLERGIC RHINITIS. CONCURRENT CONDITIONS INCLUDED: HERPES LABIALIS, VERTIGO, UPPER RESPIRATORY INFECTION AND MYOFASCIAL PAIN SYNDROME. CONCOMITANT PRODUCTS INCLUDED: ACICLOVIR, ALPRAZOLAM, AMPICILLIN, AZITHROMYCIN, CEFAZOLIN, CIPROFLOXACIN, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), DULOXETINE HYDROCHLORIDE (CYMBALTA), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NAPROXEN, ZOLPIDEM AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING, SPOTTING"). IN 2012, THE PATIENT EXPERIENCED NECK PAIN ("NECK PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("PANIC ATTACKS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY DISORDER ("ANXIETY DISORDER"), DEPRESSION ("DEPRESSION"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA OF VAGINA"), FATIGUE ("FATIGUE"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ARTHRALGIA ("MULTIPLE JOINT PAIN"), DERMAL CYST ("PILAR CYSTS ON SCALP"), EXCESSIVE GRANULATION TISSUE ("ABNL GRANULATION TISSUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("BACK PAIN"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), PAIN IN EXTREMITY ("BALL OF FOOT PAIN,WHEN I TURN A CERTAIN WAY OR SNEEZE"), SWELLING ("SWELLING") AND IRON DEFICIENCY ("IRON DEFICIENCY"). AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"), BIOPSY ENDOMETRIUM ("ENDOMETRIUM BIOPSY"). AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, SHE UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA, ANXIETY DISORDER, DEPRESSION, PANIC ATTACK, INSOMNIA, FIBROMYALGIA, MIGRAINE, HEADACHE, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, DYSURIA, BIOPSY ENDOMETRIUM, FATIGUE, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, ARTHRALGIA, DERMAL CYST, EXCESSIVE GRANULATION TISSUE, ABDOMINAL DISTENSION, NECK PAIN, BACK PAIN, VITAMIN D DEFICIENCY, PAIN IN EXTREMITY, SWELLING AND IRON DEFICIENCY OUTCOME WAS UNKNOWN. AND THE MENORRHAGIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BACTERIAL VAGINOSIS, BIOPSY ENDOMETRIUM, DEPRESSION, DERMAL CYST, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSURIA, EXCESSIVE GRANULATION TISSUE, FATIGUE, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, INSOMNIA, IRON DEFICIENCY, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PANIC ATTACK, PELVIC PAIN, SWELLING, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN D DEFICIENCY, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER PHYSICIAN DETERMINED, THAT HER PHYSICAL EXAMINATION WAS SUGGESTIVE OF ESSURE DEVICE RELATED SYMPTOMS. HER PHYSICIAN DETERMINED, TO TREAT HER SYMPTOMS THROUGH A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON AN UNKNOWN DATE, RESULTS: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE. IMAGING PROCEDURE: ON AN UNKNOWN DATE, TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: STEROSALPINGOGRAM CONFIRMED, SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. CURRENT WEIGHT 147 LBS. LOT NUMBER#: 627305, MANUFACTURING DATE: 2008/05, EXPIRATION DATE: 2010/05. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2020, QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED. INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA. SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), DYSFUNCTIONAL UTERINE BLEEDING ('DYSFUNCTIONAL UTERINE BLEEDING') AND MENORRHAGIA ('MENORRHAGIA/HEAVY MENSES') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627305) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CONJUNCTIVITIS, MENOPAUSE, ALLERGIC RHINITIS, URINARY TRACT INFECTION, UTERINE FIBROID, EUSTACHIAN TUBE DYSFUNCTION, PARATUBAL CYST AND VAGINAL DISCHARGE. CURRENT WEIGHT 147 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED HERPES LABIALIS, VERTIGO, UPPER RESPIRATORY INFECTION AND MYOFASCIAL PAIN SYNDROME. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR, ALPRAZOLAM, AMPICILLIN, AZITHROMYCIN, CEFAZOLIN, CIPROFLOXACIN, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), DULOXETINE HYDROCHLORIDE (CYMBALTA), FLUTICASONE, IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NAPROXEN, ZOLPIDEM AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING, SPOTTING"). IN 2012, THE PATIENT EXPERIENCED NECK PAIN ("NECK PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("PANIC ATTACKS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANXIETY DISORDER ("ANXIETY DISORDER"), DEPRESSION ("DEPRESSION"), INSOMNIA ("INSOMNIA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA OF VAGINA"), FATIGUE ("FATIGUE"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), ARTHRALGIA ("MULTIPLE JOINT PAIN"), DERMAL CYST ("PILAR CYSTS ON SCALP"), EXCESSIVE GRANULATION TISSUE ("ABNL GRANULATION TISSUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("BACK PAIN"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), PAIN IN EXTREMITY ("BALL OF FOOT PAIN,WHEN I TURN A CERTAIN WAY OR SNEEZE"), SWELLING ("SWELLING"), IRON DEFICIENCY ("IRON DEFICIENCY"), CARDIAC FLUTTER ("ODD FLUTTER IN MY HEART"), ARTHRITIS ("JOINT INFLAMMATION/MILD ARTHRITIS") AND PARANASAL SINUS INFLAMMATION ("SINUS INFLAMMATION") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"), BIOPSY ENDOMETRIUM ("ENDOMETRIUM BIOPSY") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH VITAMIN D NOS (VITAMIN D) AND SURGERY (ABLATION, SHE UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, CYSTOSCOPY AND ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE LEIOMYOMA, ANXIETY DISORDER, DEPRESSION, PANIC ATTACK, INSOMNIA, FIBROMYALGIA, MIGRAINE, HEADACHE, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, DYSURIA, BIOPSY ENDOMETRIUM, FATIGUE, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, ARTHRALGIA, DERMAL CYST, EXCESSIVE GRANULATION TISSUE, ABDOMINAL DISTENSION, NECK PAIN, BACK PAIN, VITAMIN D DEFICIENCY, PAIN IN EXTREMITY, SWELLING, IRON DEFICIENCY, CARDIAC FLUTTER, ARTHRITIS AND PARANASAL SINUS INFLAMMATION OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, DYSMENORRHOEA, VAGINAL HAEMORRHAGE AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANXIETY DISORDER, ARTHRALGIA, ARTHRITIS, BACK PAIN, BACTERIAL VAGINOSIS, BIOPSY ENDOMETRIUM, CARDIAC FLUTTER, DEPRESSION, DERMAL CYST, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSURIA, EXCESSIVE GRANULATION TISSUE, FATIGUE, FIBROMYALGIA, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, INSOMNIA, IRON DEFICIENCY, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PANIC ATTACK, PARANASAL SINUS INFLAMMATION, PELVIC PAIN, SWELLING, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VITAMIN D DEFICIENCY, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER PHYSICIAN DETERMINED THAT HER PHYSICAL EXAMINATION WAS SUGGESTIVE OF ESSURE DEVICE RELATED SYMPTOMS. HER PHYSICIAN DETERMINED TO TREAT HER SYMPTOMS THROUGH A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. INSERTION DETAILS- RIGHT 3 LEFT 3 COILS VISIBLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS - ON (B)(6) 2012: SMALL UTERINE FIBROID 2.1 CM RIGHT OVARIAN FOLLICLE. LOT NUMBER:627305 MANUFACTURING DATE: 2008/05 EXPIRATION DATE: 2010/05. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS:MIGRAINE, FATIGUE, INSOMNIA, LEG PAIN, HIP PAIN, FIBROMYALGIA, VITAMIN D DEFICIENCY, ANXIETY, DYSURIA, DYSMENORRHEA, MENORRHAGIA, NECK PAIN, DYSFUNCTIONAL UTERINE BLEEDING, BACTERIAL VAGINOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-SEP-2020: MR RECEIVED- NEW EVENT ODD FLUTTER IN MY HEART, JOINT INFLAMMATION/MILD ARTHRITIS, SINUS INFLAMMATION WERE ADDED. NEW REPORTER, RACE, MEDICAL HISTORY, LAB DATA, HISTORICAL. TREATMENT AND CONCOMITANT DRUG WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA") AND UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HER PHYSICIAN DETERMINED THAT HER PHYSICAL EXAMINATION WAS SUGGESTIVE OF ESSURE DEVICE RELATED SYMPTOMS. HER PHYSICIAN DETERMINED TO TREAT HER SYMPTOMS THROUGH A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE STEROSALPINGOGRAM CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 839879 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | ACICLOVIR| ACICLOVIR| ACICLOVIR| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| AMBIEN| AMBIEN| AMBIEN| AMPICILLIN| AMPICILLIN| AMPICILLIN| AMPICILLIN| AMPICILLIN| ATIVAN| ATIVAN| ATIVAN| ATIVAN| ATIVAN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| AZITHROMYCIN| CEFAZOLIN| CEFAZOLIN| CEFAZOLIN| CEFAZOLIN| CEFAZOLIN| CIPROFLOXACIN| CIPROFLOXACIN| CIPROFLOXACIN| CIPROFLOXACIN| CIPROFLOXACIN| CYMBALTA| CYMBALTA| CYMBALTA| CYMBALTA| CYMBALTA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| FLUTICASONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL| TYLENOL #3| TYLENOL #3| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3| ZOLPIDEM| ZOLPIDEM| ZOLPIDEM| ZOLPIDEM| ZOLPIDEM| ZOVIRAX| ZOVIRAX |